Classifications

• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
  • G01N35/00584—Control arrangements for automatic analysers
  • G01N35/00594—Quality control, including calibration or testing of components of the analyser
  • G01N35/00613—Quality control
  • G01N35/00623—Quality control of instruments
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
  • G16H40/40—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• • G—PHYSICS
  • G05—CONTROLLING; REGULATING
  • G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
  • G05B23/00—Testing or monitoring of control systems or parts thereof
  • G05B23/02—Electric testing or monitoring
  • G05B23/0205—Electric testing or monitoring by means of a monitoring system capable of detecting and responding to faults
  • G05B23/0259—Electric testing or monitoring by means of a monitoring system capable of detecting and responding to faults characterized by the response to fault detection
  • G05B23/0283—Predictive maintenance, e.g. involving the monitoring of a system and, based on the monitoring results, taking decisions on the maintenance schedule of the monitored system; Estimating remaining useful life [RUL]
• • G—PHYSICS
  • G06—COMPUTING; CALCULATING OR COUNTING
  • G06N—COMPUTING ARRANGEMENTS BASED ON SPECIFIC COMPUTATIONAL MODELS
  • G06N5/00—Computing arrangements using knowledge-based models
  • G06N5/04—Inference or reasoning models
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
  • G01N35/00584—Control arrangements for automatic analysers
  • G01N35/00594—Quality control, including calibration or testing of components of the analyser
  • G01N35/00613—Quality control
  • G01N35/00623—Quality control of instruments
  • G01N2035/00653—Quality control of instruments statistical methods comparing labs or apparatuses
• • G—PHYSICS
  • G06—COMPUTING; CALCULATING OR COUNTING
  • G06N—COMPUTING ARRANGEMENTS BASED ON SPECIFIC COMPUTATIONAL MODELS
  • G06N20/00—Machine learning

Definitions

• This disclosure relates to methods and apparatus for predictive quality control in diagnostic testing systems.
• diagnostic analyzers may be used to test concentrations of certain constituents found in biological specimens, such as, e.g., blood, urine, cerebrospinal liquids, and like fluid samples. Such diagnostic analyzers may be complex and may perform hundreds or even thousands of diagnostic tests each day. In order to ensure that the results produced by a diagnostic analyzer are valid, quality control tests may be performed thereon using quality control samples that should produce expected results. Quality controls tests may be performed, for example, at the beginning of each shift, after a
• diagnostic analyzer is serviced or calibrated, when reagent lots are changed, after a certain period of time has elapsed, after a certain number of diagnostic tests have been
• the diagnostic analyzer may be considered "out of control.” That is, the diagnostic analyzer is operating unacceptably and all of the results produced by that
• a quality control method includes receiving, at a controller, analyzer results from a diagnostic analyzer in response to executing a quality control test;
• a quality control apparatus includes a diagnostic analyzer configured to perform one or more tests on biological specimens, a controller in electronic
• the controller includes a communication interface configured to receive (1) analyzer results from the diagnostic analyzer in response to the diagnostic analyzer executing a quality control test, and (2) data related to the diagnostic analyzer.
• the controller also includes a decision module configured and operable to analyze the analyzer results and the data related to the diagnostic analyzer in order to determine whether the diagnostic analyzer is operating acceptably, unacceptably, or acceptably now but subsequently may not continue to do so.
• FIG. 1 illustrates a timeline of known quality control performed on a diagnostic analyzer.
• FIG. 2 illustrates a schematic block diagram of a quality control apparatus according to embodiments.
• FIG. 3 illustrates a flowchart of a quality control method according to embodiments.
• In vitro diagnostic analyzers may rely on quality control tests to ensure that the results produced by the diagnostic analyzers are valid.
• a quality control test involves testing a quality control sample in the diagnostic analyzer and comparing the analyzer result with an expected result for that quality control sample. If a diagnostic analyzer does not produce the expected result from a quality control test, the diagnostic analyzer may be considered to be "out of control" and all of the results produced by that diagnostic analyzer since the last successful quality control test may now be called into question.
• FIG. 1 shows a timeline 100 of
• a first quality control test according to the prior art may be performed at, e.g., 12:00 AM that may indicate that the diagnostic analyzer is operating acceptably (i.e., the analyzer results correspond to the expected results of the first quality control test) .
• a second quality control test according to the prior art may be performed at, e.g., 8:00 AM that may also indicate that the diagnostic analyzer is operating acceptably. This successful second quality control test may ensure that all of the analyzer results produced between 12:00 AM and 8:00 AM are reliable and valid.
• a third quality control test according to the prior art may be performed at 4:00 PM that may indicate that the diagnostic analyzer is not operating acceptably (i.e., the analyzer results do not correspond to the expected results of the third quality control test) .
• one or more embodiments of the disclosure provide predictive quality control methods and apparatus configured and operable to predict when a diagnostic analyzer may no longer operate acceptably. These methods and apparatus may obtain and analyze other data related to the operation of the diagnostic analyzer on a continual basis in addition to comparing analyzer results from a quality control test with expected results of the quality control test. The analysis of the related data may indicate that although the diagnostic analyzer is currently operating acceptably (i.e., the analyzer results from the quality control test correspond to the expected results), the diagnostic analyzer may not continue to operate acceptably in the near future. In some embodiments, the analysis may provide an estimated time frame within which the diagnostic analyzer may be "out of control.” Thus, referring to FIG.
• performing predictive quality control may indicate based on the continual receipt and analysis of related data that while the diagnostic analyzer is currently operating acceptably, it may not continue to do so within, e.g., the next 2-4 hours.
• Such an indication which may occur at any time during or between quality control tests, may allow a user of the diagnostic analyzer to initiate remedial procedures before continuing with possibly thousands of diagnostic tests, thus saving time, reducing costs, and possibly improving patient safety by avoiding the production of possibly invalid analyzer results.
• the predictive quality control methods and apparatus according to embodiments may further save time and reduce costs by allowing quality control tests to be performed less often. That is, because the predictive quality control methods and apparatus according to embodiments are configured to alert a user of possibly unacceptable operation before such unacceptable operation actually occurs, a diagnostic analyzer may be allowed to operate for longer periods of time between quality control tests.
• FIG. 2 illustrates a quality control apparatus 200 according to embodiments.
• Quality control apparatus 200 may include a diagnostic analyzer 202, a controller 204, a user interface 206, one or more sensors 208, optional external data sources 210, and quality control sample specimens 212.
• Diagnostic analyzer 202 may be configured to perform one or more diagnostic tests and/or analyses on biological specimens.
• Quality control apparatus 200 is configured and operative to predictively indicate when operation of diagnostic analyzer 202 may no longer be acceptable. In other words, quality control apparatus 200 is configured and operative to
• Controller 204 may include a memory 214 (e.g., RAM, ROM, or other) configured to store programming instructions, test result data, and/or other information/data. Controller 204 may also include a processor 216 (e.g., a CPU, microprocessor, or the like) configured to execute programming instructions in connection with the operation of quality control apparatus 200, including the performing of quality control tests on diagnostic analyzer 202. Controller 204 may further include a communication interface 218 via which controller 204 may be coupled to and in electronic communication with diagnostic analyzer 202, user interface 206, sensors 208, external sources 210, and apparatus 213 for transporting a quality control sample specimen 212 into diagnostic analyzer 202.
• a communication interface 218 via which controller 204 may be coupled to and in electronic communication with diagnostic analyzer 202, user interface 206, sensors 208, external sources 210, and apparatus 213 for transporting a quality control sample specimen 212 into diagnostic analyzer 202.
• communication interface 218 may enable communication with a network (not shown) coupled between controller 204 and one or more of the other components of quality control apparatus 200.
• the network may include, e.g., a local area network (LAN) , a wireless local area network (WLAN), a power line communication (PLC) network, or the like.
• LAN local area network
• WLAN wireless local area network
• PLC power line communication
• Communication interface 218 may be configured to receive analyzer results from diagnostic analyzer 202 in response to diagnostic analyzer 202 executing a quality control test. Communication interface 218 may also be configured to receive data related to diagnostic analyzer 202 obtained from sensors 208 and/or external sources 210.
• the data related to diagnostic analyzer 202 may be provided by the one or more sensors 208 and/or the one or more external sources 210 on a continual basis.
• External sources 210 may include manually provided data.
• Sensors 208 e.g., thermometers, bar code readers, barometers, etc.
• This related data may include, but not be limited to, one or more of the following: a sequence, number, or type of tests previously performed by diagnostic analyzer 202; internal temperature of diagnostic analyzer 202; level of internal vibrations of diagnostic analyzer 202; humidity level; atmospheric pressure; degree of water ionization;
• refrigerated storage temperature of reagents and/or other specimen sample additives may additionally or alternatively be included.
• Controller 204 may also include a decision module 215 stored in memory 214 and executable by processor 216.
• the decision module 215 may be configured and operable to compare the analyzer results with expected results from a quality control test.
• the decision module 215 may also be configured and operable to analyze the analyzer results and the data related to diagnostic analyzer 202 to determine whether diagnostic analyzer 202 is operating acceptably, unacceptably, or acceptably now but subsequently may not.
• the decision module 215 may include an artificial intelligence-driven model trained to identify patterns in the data related to diagnostic analyzer 202 that may indicate subsequent unacceptable diagnostic analyzer operation.
• quality control data stored in memory 214 may indicate that acceptable analyzer operation (i.e., analyzer results corresponding to expected results of a quality control test) may be associated with related data having a first set or range of one or more values, while unacceptable analyzer operation (i.e., analyzer results not corresponding to expected results of a quality control test) may be associated with related data having a second set or range of one or more values.
• decision module 215 may determine that diagnostic analyzer 202 may not continue operating acceptably and may prompt controller 204 to issue a warning message to user interface 206.
• decision module 215 may provide a time frame (e.g., within the next 3-5 hours) during which unacceptable analyzer operation may be expected. This time frame may be based on, e.g., how quickly the one or more values between the first and second sets or ranges of values may be moving toward the second set or range of values.
• User interface 206 may include a display device 207 configured to display messages received from controller 204. The messages may indicate that diagnostic analyzer 202 is operating acceptably, unacceptably, or acceptably now but subsequently may not. In some embodiments, user interface 206 may also include an audible warning device 209 that may be configured to activate in response to a message sent from controller 204 indicating that diagnostic analyzer 202 is operating either unacceptably or acceptably now but
• FIG. 3 shows a quality control method 300 according to embodiments.
• Method 300 may be carried out by, e.g., controller 204 and diagnostic analyzer 202 of quality control apparatus 200.
• Method 300 may include, in process block 302, receiving, at a controller, analyzer results from a diagnostic analyzer in response to executing a quality control test.
• controller 204 may initiate a quality control test by directing a quality control sample specimen 212 to be transported to diagnostic analyzer 202 for a quality control test. Controller 204 may then receive the analyzer results of that quality control test from diagnostic analyzer 202.
• Method 300 may also include, in process block 304, receiving, at the controller, data related to the diagnostic analyzer.
• sensors 208 and/or external sources 210 may continually provide to controller 204 related data, such as, e.g., one or more of previous testing information, reagent information, equipment status, and/or environmental readings or measurements (e.g., temperature, humidity, vibration, atmospheric pressure, etc.) .
• method 300 may include analyzing, with a decision module executing in the controller, the analyzer results and the data related to the diagnostic analyzer.
• decision module 215 may compare the analyzer results with the expected results for the tested quality control sample specimen 212 and may further analyze the data related to the diagnostic analyzer in view of previously stored data related to diagnostic analyzer 202 in order to determine the operational status of diagnostic analyzer 202 and predict subsequent operational status of diagnostic analyzer 202.
• method 300 may include sending, from the controller to a user interface, a message indicating that the diagnostic analyzer is operating
• controller 204 may send a message to user interface 206 indicating the operational status of diagnostic analyzer 202.
• Controller 204 additionally or alternatively may activate audible warning device 209 in response to sending a message to user interface 206 indicating that diagnostic analyzer 202 is operating either unacceptably or acceptably now but subsequently may not continue to do so.

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• 2019
  • 2019-02-11 US US16/961,982 patent/US20210081839A1/en active Pending
  • 2019-02-11 EP EP19767934.3A patent/EP3764882A4/de active Pending
  • 2019-02-11 WO PCT/US2019/017458 patent/WO2019177724A2/en unknown

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